Hoth Therapeutics Achieves EU Regulatory Approval for HT-001 Clinical Program
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Jan 15 2026
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Should l Buy HOTH?
Hoth Therapeutics has achieved a major European regulatory milestone for its HT-001 clinical program targeting cancer patients undergoing EGFR inhibitor therapies. The company received a positive regulatory conclusion under the European Union Clinical Trials Information System, or CTIS, for Part I. This determination confirms the scientific and regulatory acceptability of the trial design and investigational products. Hoth expects to activate clinical trial sites and initiate the study across multiple European countries. In parallel, country-specific Part II regulatory decisions in Hungary, Spain, and Poland are expected by January 19. The HT-001 program is being developed to address EGFRI-induced dermatologic toxicities, a common and often dose-limiting complication experienced by cancer patients undergoing treatment.
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Analyst Views on HOTH
About HOTH
Hoth Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on developing new generation therapies for unmet medical needs. The Company is focused on developing a topical formulation for treating side effects from drugs used for the treatment of cancer (HT-001); a treatment for mast-cell derived cancers and anaphylaxis (HT-KIT), and a treatment and/or prevention for Alzheimer's or other neuroinflammatory diseases (HT-ALZ). The Company also has assets being developed for atopic dermatitis (also known as eczema) (BioLexa); a treatment for asthma and allergies using inhalational administration (HT-004), and a treatment for obesity, and obesity-related diseases and conditions (HT-VA).
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
Hoth Therapeutics Reports Significant Clinical Results from HT-001 Trial in Cancer Patients
- Clinical Response Rate: In the open-label PK cohort of the CLEER-001 trial, 100% of evaluable patients achieved a clinical response by Week 6, demonstrating the efficacy of HT-001 in cancer patients and potentially laying the groundwork for future treatment options.
- Disease Severity Improvement: There was approximately a 50% reduction in disease severity (ARIGA score) from baseline, with all evaluable patients reaching ARIGA ≤1 by Week 6, indicating significant and durable treatment effects that enhance the company's competitive position in oncology.
- Reduction in Side Effects: Supportive clinical endpoints showed a ~34% improvement in oncology toxicity (CTCAE) and a ~37% reduction in patient-reported pruritus, highlighting a broad and consistent treatment effect across multiple clinically relevant measures, which may improve patient quality of life.
- Market Performance Analysis: Hoth Therapeutics' stock is currently trading at $1.075, 2.7% below its 20-day simple moving average, indicating a bearish trend in the short term, although analysts maintain a 'Buy' rating with a price target of $6.50, reflecting confidence in the company's future potential.
See More
Hoth Therapeutics Reports 50% Improvement in Cancer Patients with HT-001 in CLEER-001 Trial
- Primary Endpoint Improvement: In the CLEER-001 trial's open-label PK cohort, HT-001 reduced ARIGA scores from a baseline of 1.67 to 0.83, representing a ~50% improvement in disease severity, with all evaluable patients achieving low-severity status by Week 6, demonstrating rapid onset and durability of response.
- Oncology Toxicity Reduction: HT-001 showed significant improvements in additional endpoints, with a ~34% reduction in oncology toxicity (CTCAE) and a ~37% decrease in patient-reported pruritus, indicating a broad and consistent treatment effect across multiple clinically relevant measures.
- Favorable Tolerability: HT-001 was well tolerated in the open-label PK cohort, with no unexpected safety signals observed, supporting the efficacy of the selected dosing regimen and continued clinical development.
- Potential Supportive Care: The results highlight HT-001's potential as an important oncology supportive-care therapy, aiding patients in maintaining effective cancer treatments and improving their quality of life amidst the challenges posed by EGFR inhibitors.
See More
Hoth Therapeutics Reports Significant Improvement in Cancer Patients' Condition in Clinical Trial
- Primary Endpoint Improvement: In the CLEER-001 clinical trial's open-label PK cohort, all evaluable patients showed a significant reduction in ARIGA scores from 1.67 at baseline to 0.83 by Week 6, indicating a ~50% improvement in disease severity and highlighting HT-001's efficacy in cancer treatment.
- Oncology Toxicity Reduction: HT-001 demonstrated a notable ~34% improvement in treatment-related toxicity, with CTCAE scores decreasing from 2.0 at baseline to 1.33, suggesting that this therapy can alleviate the burden of treatment-related side effects and enhance treatment continuity.
- Pruritus Symptom Relief: Patient-reported pruritus scores improved significantly, dropping from 4.22 at baseline to 2.67, representing a ~37% reduction that exceeds clinically meaningful thresholds, thereby enhancing patient comfort and adherence to treatment.
- Favorable Tolerability: HT-001 was well tolerated in the open-label PK cohort with no unexpected safety signals, supporting its continued clinical development and underscoring its potential role in oncology supportive care.
See More
Hoth Therapeutics Secures China Patent for HT-KIT, Enhancing Oncology Market Protection
- Patent Approval: Hoth Therapeutics announced the approval of its HT-KIT cancer program patent in China, marking a significant enhancement of its intellectual property protection in the global oncology market, which is expected to boost the company's competitiveness in the rapidly growing Chinese biopharmaceutical sector.
- Technological Innovation: HT-KIT is designed to induce apoptosis in cancer cells by targeting KIT signaling pathways, aiming to selectively impact diseased cells while avoiding the systemic toxicity associated with traditional cytotoxic therapies, thus providing safer treatment options for patients.
- Market Strategy: As one of the largest oncology drug markets globally, patent protection in China will provide crucial support for Hoth in future partnerships, licensing, and strategic transactions, further enhancing its commercial value and market position.
- Global IP Portfolio: The acquisition of the HT-KIT patent represents a significant step for Hoth in expanding its portfolio of oncology and immunology assets, reflecting the company's commitment to creating long-term shareholder value through IP-driven drug development.
See More
Hoth Therapeutics Secures China Patent for HT-KIT, Enhancing Oncology Market Protection
- Patent Approval: Hoth Therapeutics announced the approval of its HT-KIT cancer program patent in China, a novel therapeutic approach designed to induce apoptosis in cancer cells by targeting KIT signaling pathways, further solidifying its intellectual property position in the global oncology market.
- Market Potential: As one of the largest oncology markets globally, patent protection in China will significantly enhance Hoth's commercial value in future partnerships, licensing, and strategic transactions, positioning the company favorably in the rapidly growing biopharmaceutical sector.
- Technological Innovation: HT-KIT aims to selectively impact disease-relevant cells by disrupting aberrant KIT-driven signaling, avoiding the systemic toxicity associated with traditional cytotoxic therapies, thereby providing safer treatment options and improving therapeutic outcomes for patients.
- Global Strategic Positioning: The patent issuance marks a successful conversion of Hoth's international patent filings into issued assets, which is expected to attract biotech investors' attention and lay a foundation for the company's future R&D and market expansion.
See More
Hoth Therapeutics Achieves Positive EU CTIS Conclusion, Near-Term Clinical Trial for Cancer Patients Set to Initiate
- Regulatory Milestone: Hoth Therapeutics has achieved a positive conclusion under the EU Clinical Trials Information System for its HT-001 clinical program, confirming the scientific and regulatory acceptability of the trial design and investigational products, marking a significant advancement in the oncology sector.
- Multi-Country Trial Launch: The company expects to activate clinical trial sites and initiate the study across multiple European countries, rapidly advancing multi-national clinical execution to meet the urgent demand for new therapies among cancer patients.
- Targeted Treatment Development: The HT-001 program aims to address EGFR inhibitor-induced dermatologic toxicities, a common side effect that negatively impacts cancer patients' quality of life and increases healthcare burdens, with Hoth's new therapy poised to enhance patient treatment experiences.
- Rapid Decision Anticipation: Hoth expects to receive country-specific Part II regulatory decisions in Hungary, Spain, and Poland by January 19, 2026, thereby accelerating the overall clinical trial process and further solidifying its market position in oncology.
See More
Hoth Therapeutics Reports Significant Clinical Results from HT-001 Trial in Cancer Patients
- Clinical Response Rate: In the open-label PK cohort of the CLEER-001 trial, 100% of evaluable patients achieved a clinical response by Week 6, demonstrating the efficacy of HT-001 in cancer patients and potentially laying the groundwork for future treatment options.
- Disease Severity Improvement: There was approximately a 50% reduction in disease severity (ARIGA score) from baseline, with all evaluable patients reaching ARIGA ≤1 by Week 6, indicating significant and durable treatment effects that enhance the company's competitive position in oncology.
- Reduction in Side Effects: Supportive clinical endpoints showed a ~34% improvement in oncology toxicity (CTCAE) and a ~37% reduction in patient-reported pruritus, highlighting a broad and consistent treatment effect across multiple clinically relevant measures, which may improve patient quality of life.
- Market Performance Analysis: Hoth Therapeutics' stock is currently trading at $1.075, 2.7% below its 20-day simple moving average, indicating a bearish trend in the short term, although analysts maintain a 'Buy' rating with a price target of $6.50, reflecting confidence in the company's future potential.
See More
Hoth Therapeutics Reports 50% Improvement in Cancer Patients with HT-001 in CLEER-001 Trial
- Primary Endpoint Improvement: In the CLEER-001 trial's open-label PK cohort, HT-001 reduced ARIGA scores from a baseline of 1.67 to 0.83, representing a ~50% improvement in disease severity, with all evaluable patients achieving low-severity status by Week 6, demonstrating rapid onset and durability of response.
- Oncology Toxicity Reduction: HT-001 showed significant improvements in additional endpoints, with a ~34% reduction in oncology toxicity (CTCAE) and a ~37% decrease in patient-reported pruritus, indicating a broad and consistent treatment effect across multiple clinically relevant measures.
- Favorable Tolerability: HT-001 was well tolerated in the open-label PK cohort, with no unexpected safety signals observed, supporting the efficacy of the selected dosing regimen and continued clinical development.
- Potential Supportive Care: The results highlight HT-001's potential as an important oncology supportive-care therapy, aiding patients in maintaining effective cancer treatments and improving their quality of life amidst the challenges posed by EGFR inhibitors.
See More
Hoth Therapeutics Reports Significant Improvement in Cancer Patients' Condition in Clinical Trial
- Primary Endpoint Improvement: In the CLEER-001 clinical trial's open-label PK cohort, all evaluable patients showed a significant reduction in ARIGA scores from 1.67 at baseline to 0.83 by Week 6, indicating a ~50% improvement in disease severity and highlighting HT-001's efficacy in cancer treatment.
- Oncology Toxicity Reduction: HT-001 demonstrated a notable ~34% improvement in treatment-related toxicity, with CTCAE scores decreasing from 2.0 at baseline to 1.33, suggesting that this therapy can alleviate the burden of treatment-related side effects and enhance treatment continuity.
- Pruritus Symptom Relief: Patient-reported pruritus scores improved significantly, dropping from 4.22 at baseline to 2.67, representing a ~37% reduction that exceeds clinically meaningful thresholds, thereby enhancing patient comfort and adherence to treatment.
- Favorable Tolerability: HT-001 was well tolerated in the open-label PK cohort with no unexpected safety signals, supporting its continued clinical development and underscoring its potential role in oncology supportive care.
See More
Hoth Therapeutics Secures China Patent for HT-KIT, Enhancing Oncology Market Protection
- Patent Approval: Hoth Therapeutics announced the approval of its HT-KIT cancer program patent in China, marking a significant enhancement of its intellectual property protection in the global oncology market, which is expected to boost the company's competitiveness in the rapidly growing Chinese biopharmaceutical sector.
- Technological Innovation: HT-KIT is designed to induce apoptosis in cancer cells by targeting KIT signaling pathways, aiming to selectively impact diseased cells while avoiding the systemic toxicity associated with traditional cytotoxic therapies, thus providing safer treatment options for patients.
- Market Strategy: As one of the largest oncology drug markets globally, patent protection in China will provide crucial support for Hoth in future partnerships, licensing, and strategic transactions, further enhancing its commercial value and market position.
- Global IP Portfolio: The acquisition of the HT-KIT patent represents a significant step for Hoth in expanding its portfolio of oncology and immunology assets, reflecting the company's commitment to creating long-term shareholder value through IP-driven drug development.
See More
Hoth Therapeutics Secures China Patent for HT-KIT, Enhancing Oncology Market Protection
- Patent Approval: Hoth Therapeutics announced the approval of its HT-KIT cancer program patent in China, a novel therapeutic approach designed to induce apoptosis in cancer cells by targeting KIT signaling pathways, further solidifying its intellectual property position in the global oncology market.
- Market Potential: As one of the largest oncology markets globally, patent protection in China will significantly enhance Hoth's commercial value in future partnerships, licensing, and strategic transactions, positioning the company favorably in the rapidly growing biopharmaceutical sector.
- Technological Innovation: HT-KIT aims to selectively impact disease-relevant cells by disrupting aberrant KIT-driven signaling, avoiding the systemic toxicity associated with traditional cytotoxic therapies, thereby providing safer treatment options and improving therapeutic outcomes for patients.
- Global Strategic Positioning: The patent issuance marks a successful conversion of Hoth's international patent filings into issued assets, which is expected to attract biotech investors' attention and lay a foundation for the company's future R&D and market expansion.
See More
Hoth Therapeutics Achieves Positive EU CTIS Conclusion, Near-Term Clinical Trial for Cancer Patients Set to Initiate
- Regulatory Milestone: Hoth Therapeutics has achieved a positive conclusion under the EU Clinical Trials Information System for its HT-001 clinical program, confirming the scientific and regulatory acceptability of the trial design and investigational products, marking a significant advancement in the oncology sector.
- Multi-Country Trial Launch: The company expects to activate clinical trial sites and initiate the study across multiple European countries, rapidly advancing multi-national clinical execution to meet the urgent demand for new therapies among cancer patients.
- Targeted Treatment Development: The HT-001 program aims to address EGFR inhibitor-induced dermatologic toxicities, a common side effect that negatively impacts cancer patients' quality of life and increases healthcare burdens, with Hoth's new therapy poised to enhance patient treatment experiences.
- Rapid Decision Anticipation: Hoth expects to receive country-specific Part II regulatory decisions in Hungary, Spain, and Poland by January 19, 2026, thereby accelerating the overall clinical trial process and further solidifying its market position in oncology.
See More
